Hamilton, Bermuda, December 1, 2020 - Auris Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, rhinology and allergy and CNS disorders, today announced positive efficacy data from testing AM-301 in vitro. AM-301 is a drug-free nasal spray being developed by the Company's affiliate Altamira Medica for protection against airborne pathogens and allergens.
AM-301 was tested for its capability to prevent or mitigate SARS-CoV-2 infection of nasal epithelial cells, which are part of the nasal mucosa and the first barrier against continuously inhaled substances such as pathogens and allergens. The experiment was performed over four days on reconstituted human nasal epithelia, which are frequently used to study the effects of human respiratory viruses. In saline-treated control cultures, Sars-CoV-2 replicated efficiently, resulting in a rapid increase in viral titer (as measured by the Median Tissue Culture Infectious Dose, TCID50). In contrast, daily treatment with AM-301, beginning right before inoculation, showed effective protection against viral infection. 48 hours post-infection, average virus titers were 90.0% lower than those observed in controls (p<0.05). 72 hours and 96 hours post-infection, average virus titers were 99.2 and 99.4% lower, respectively (p<0.001). Even when unbound virus was not removed daily through apical washing, allowing the virus to accumulate in the culture for 4 days, the reduction in viral titer was 92.4% compared to saline-treated controls (p<0.001).
"We are very excited to see the protective effects of AM-301 against Sars-CoV-2 confirmed in an assay that very closely replicates real-life conditions in the human nose", commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. "Our first experiments in September showed that AM-301's key component trapped up to 99% of Sars-CoV-2 when brought into contact with a viral suspension. Now, with our newly developed spray formulation, we have direct evidence that AM-301 has the potential to significantly mitigate the risk of infection of nasal mucosal cells. We look forward to taking AM-301 through additional tests and advancing the program towards the submission of regulatory applications in 2021."
AM-301 is a drug-free nasal spray for personal protection against airborne pathogens and allergens. Upon application into the nose, AM-301 forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of viruses or other pathogens and allergens with cells; in addition, the composition serves to "trap" such particles and help with their discharge. Together, this is designed to reduce the risk of upper respiratory infections and promote alleviation of allergic symptoms.
About Auris Medical
Auris Medical is a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, rhinology and allergy and CNS disorders. The Company is focused on the development of intranasal betahistine for the treatment of vertigo (AM-125, in Phase 2) and for the prevention of antipsychotic-induced weight gain and somnolence (AM-201, post Phase 1b). Through its affiliate Altamira Medica, the Company is developing a nasal spray for protection against airborne pathogens and allergens (AM-301). In addition, Auris Medical has two Phase 3 programs under development: Sonsuvi® (AM-111) for acute inner ear hearing loss and Keyzilen® (AM-101) for acute inner ear tinnitus. The Company was founded in 2003 and is headquartered in Hamilton, Bermuda with its main operations in Basel, Switzerland. The shares of Auris Medical Holding Ltd. trade on the NASDAQ Capital Market under the symbol "EARS."
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